OsteoFlo HydroFiber
K-Number: K251720 · 2025-07-02
ApplicantSurGenTec, LLC
Decision Date2025-07-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OsteoFlo HydroFiber is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2025-07-02 under approval number K251720. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OsteoFlo HydroFiber?
OsteoFlo HydroFiber is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by SurGenTec, LLC. The 510(k) number is K251720.
When was OsteoFlo HydroFiber approved by the FDA?
OsteoFlo HydroFiber received FDA 510(k) clearance on 2025-07-02, under approval number K251720.
What company makes OsteoFlo HydroFiber?
OsteoFlo HydroFiber is manufactured by SurGenTec, LLC.
What is the FDA product code for OsteoFlo HydroFiber?
The FDA product code for OsteoFlo HydroFiber is MQV.
Other Devices by SurGenTec, LLC
Related Devices (Code: MQV)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.